Director, Clinical Research
$255,000–$345,000 year
HybridPhiladelphia, Pennsylvania, United States or Cambridge, Massachusetts, United States
Job Summary
Director, Clinical Research leading as a clinical lead in a regulatory-focused development program for RNAi therapeutics, with a focus on ATTR amyloidosis. The role reports to the program medical lead, collaborates across Regulatory, Biostatistics, Clinical Operations, Preclinical, Commercial & Quality Assurance teams, and serves as a key spokesperson at external meetings and regulatory interactions. This hybrid position requires two onsite days per week in Cambridge, MA or Philadelphia, PA, and involves steering clinical development strategies, overseeing trial conduct and safety, coordinating with Research on feasibility and proof-of-concept studies, and guiding written deliverables and regulatory submissions. Responsibilities include strategic leadership for the clinical program, cross-functional integration of product development plans, and ensuring timely deliverables and global regulatory approvals, with extensive external collaboration and potential opportunities to lead early-phase programs.
Required Qualifications
- MD with strong research background or MD PhD with best of class clinical and/or research training as shown through research support and peer-reviewed publications
- Board Certification (or equivalent) or specialist training in cardiology
- Experience and knowledge of working with biotech/pharma partner(s)
- 3+ years industry experience or equivalent clinical academic experience
- Familiarity with concepts of clinical research and clinical trial design, including biostatistics, and regulatory agency organization, guidelines, and practices
- Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication
- Outstanding leadership and collaboration skills working within a matrix environment
- History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues
- Thrive in entrepreneurial biotech environment and embrace company culture
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